Mammacarcinoma Breastcancer
Conditions
Interventions
Patients in the intervention group will undergo breast reconstruction using AFT. The control group will receive a standard DIEP flap reconstruction. 
Sponsors
Maastricht Universitair Medisch Centrum +
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Female, aged =18 years.BMI between =22 and =35 kg/m2History of breast cancer treated with mastectomy (minimally 3 months after mastectomy) and post mastectomy chest wall radiotherapy (completed =6 months before enrollment).May include contralateral/bilateral prophylactic mastectomy if at least one side had cancer and radiation.Desires autologous breast reconstruction and accepts randomization between AFT and DIEP.Medically fit for surgery (ASA I–III).Sufficient donor tissue for both AFT (enough fat) and DIEP (suitable abdominal tissue and vasculature).No evidence of active cancer at enrollment; remission confirmed.Able to wear the EVE device (if randomized in AFT).Capable of understanding study information and questionnaires (Dutch or English), willing to give informed consent, and able to comply with follow-up.
Exclusion criteria
Exclusion criteria: • Prior autologous breast reconstruction on the intended side. • BMI <22 or >35 kg/m2 • Contraindication to DIEP flap (e.g., prior abdominoplasty or abdominal scars affecting perforators). • Contraindication to AFT (e.g., insufficient fat or conditions impairing fat graft viability). • Current chemotherapy or completed less than 4 weeks prior to enrollment. • Serious uncontrolled comorbidities making elective surgery unsafe (e.g., unstable heart disease, severe coagulopathy, end-stage organ failure). • Active smoker or not abstinent for at least 6 weeks pre-operatively. • Pregnant at time of enrollment. • In case low compliance is expected or an inability to comply with study protocol, in-cluding unwillingness to undergo either AFT or DIEP, or inability to complete follow-up (due to language, cognitive issues, or relocation plans). • Previous enrollment in this trial (patients can only be included once, even if later pre-senting for contralateral reconstruction). • Allergy to lidocaine or silicone
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoints are the score on the “Satisfaction with breasts” domain of the BREAST-Q at 12 months, the incidence of major complications, and cost-effectiveness. Secondary endpoints include minor complication rates, volume of the reconstructed breast, skin quality, sensation of the breast, and oncologic follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objectives include comparing the following parameters for both patient groups:Patient-Reported Outcomes: All other BREAST-Q domains (Physical Well-being (chest and donor site), Psychosocial Well-being, Sexual Well-being, Breast Sensation, and Adverse Effects of Radiation), and donor-site satisfaction (assessed with the BODY-Q questionnaire).Complications (Minor & General): Incidence of minor recipient-site and donor-site complications (i.e. complications taking care of at the outpatient clinic) managed conservatively (e.g. wound problems/dehiscence, infection, seroma, hematoma, and abdominal bulging), and any general (systemic) complications related to surgery or hospitalization (e.g. pulmonary embolism, pneumonia).Oncologic Safety: Monitor and compare breast cancer recurrence rates using routine follow-up and PALGA registry to confirm AFT’s oncologic safety. Sensory Recovery: Evaluate return of breast skin sensation at 12 months with monofilament testing to compare sensory outcomes between techniques [in MUMC+ only].Physical Function and Pain: Compare post-mastectomy pain and functional limitations (e.g., shoulder mobility, abdominal strength) using patient-reported outcomes and clinical exams.Breast Aesthetics & Volume: Breast volume and shape assessed 12 months after reconstruction using 3D Vectra photography and the BREAST-V volume calculator. Fat graft retention in the AFT group will be estimated by total grafted volume versus final breast volume. Standardized photographs (2D and 3D) will document cosmetic outcomes which can be assessed by a an expert panel.Radiation-Associated Changes: Grade radiation-related tissue changes with the Common Terminology Criteria for Adverse Events (CTCAE) score to assess whether AFT improves pliability or fibrosis compared to DIEP flap breast reconstruction.In summary, the study aims to comprehensively evaluate effectiveness, safety, patient-centered outcomes, and economic impact of AFT versus DI | — |
Countries
Netherlands
Contacts
Public ContactZMA Kuijlaars
Maastricht Universitair Medisch Centrum +
Outcome results
None listed